# Clinical Core

> **NIH NIH P50** · YALE UNIVERSITY · 2021 · $485,569

## Abstract

Clinical Core
Stephanie S. O’Malley, Ph.D.
Abstract
The Clinical Core serves an important function as the central resource for the diverse CTNA projects and
pilots. The opportunity to fund a central core with a distinguished leader provides a programmatic method to
define needs and assign resources to address central issues. The central components of the Clinical Core
are oversight of subject recruitment, participant safety and clinical assessments in human studies, and data
management and biostatistical support for all Center projects. The Core also oversees the creation of a cross-
project “Core Database” for investigating phenotypes relevant to the CTNA and its mission. The specific aims
for this core are:
A. Centralized monitoring and recruitment of subjects to: 1) Enhance the efficiency of enrollment into each
 project, including pilots; 2) Ensure the safety of participants and 3) Update the Principal Investigators (PIs),
 the Steering Committee, the Program Advisory Committee, and the Data Safety Monitoring Board of
 progress on the protocols.
B. Central oversight of assessments to: 1) Provide efficiency in training and assessment; 2) Maintain
 consistency in the administration of assessments; 3) Enhance the ability of investigators to pool data
 across studies; 4) Ensure that validated and current assessment tools are used; and 5) Support secondary
 analyses utilizing core assessments from the Core database.
C. Central provision of data management and biostatistics support to: 1) Provide design and analytical
expertise to meet the goals of the CTNA scientific agenda; 2) Provide state-of-the-science methods for
data management; 3) Generate randomization lists and assess randomization implementation; 4) Interface
with specialized data analysis expertise related to particular technologies associated with the CTNA,
including genetics and imaging; 5) Prepare reports related to the progress of clinical studies for the Data
Safety Monitoring Board, FDA and NIH; 6) Provide statistical support for all investigators; and 7) Create
data structure and uploads required for the provision of data to the NIAAA Data Archive.

## Key facts

- **NIH application ID:** 10056549
- **Project number:** 2P50AA012870-21
- **Recipient organization:** YALE UNIVERSITY
- **Principal Investigator:** STEPHANIE S O'MALLEY
- **Activity code:** P50 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $485,569
- **Award type:** 2
- **Project period:** 2001-06-04 → 2026-05-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10056549

## Citation

> US National Institutes of Health, RePORTER application 10056549, Clinical Core (2P50AA012870-21). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/10056549. Licensed CC0.

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